On Wednesday, Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for excessive daytime sleepiness ...
(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) said Monday that a pivotal bioequivalence (BE) study of its pitolisant gastro-resistant (GR) formulation showed that 17.8 mg of pitolisant GR is ...
PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter for its supplemental ...
An open-label, long-term (up to five years) study of pitolisant in patients with narcolepsy. The manuscript focuses on findings from a one-year analysis that assessed the long-term safety and efficacy ...
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration ...
Harmony Biosciences Holdings, Inc. (HRMY) has already been able to receive FDA approval for its drug known as WAKIX [PITOLISANT]. It is for excessive daytime sleepiness [EDS] or cataplexy in adult ...
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant gastro-resistant (GR) formulation. With positive ...
PITTSBURGH, Oct. 15, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has acquired Aculys Pharma, Inc., a clinical stage biopharmaceutical company ...
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